Tapered Screw-Vent® TSVT4B13Recalls & reported problems

Summary

The FDA's MAUDE database contains 158 adverse event reports that list this exact device (DI 00889024019843), received between Sep 11, 2019 and May 7, 2026 — classified as 145 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (6 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 158 reports, in the reporter's own words as published by the FDA.

• InjuryMay 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AT TWO MONTHS, WHEN WE REMOVED THE COVER SCREW; GRANULATION TISSUE HAD PUSHED THE IMPLANT OUT OF THE ORIGINAL PLACEMENT SITE. THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION & PAIN. TOOTH LOCATION WAS NOT PROVIDED.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 25111220 ↗
• InjuryMay 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 3 IMPLANTS AT TOOTH SITES #23, 25 AND 26 WERE REMOVED DUE TO A BONE LOSS. OSSEOINTEGRATED IMPLANTS FOR 6 MONTHS THAT HAVE COMPLETELY RESORBED THE BUCCAL BONE PLATE. PROCEDURE WAS COMPLETED.

  Patient problems: Osteolysis

  MAUDE report 25109617 ↗
• MalfunctionFeb 16, 2026Separation Failure

  DOCTOR REPORTED THAT MOUNT SCREW CANNOT BE DISENGAGED FROM IMPLANT AT TOOTH SITE 27, BEFORE IMPLANTATION DOCTOR UNSCREWED THE SCREW ONCE. DOCTOR CONFIRMED THAT PROCEDURE WAS COMPLETED WITH ANOTHER IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24342244 ↗
• InjuryFeb 13, 2026Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 24338482 ↗
• InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #20 WAS REMOVED DUE TO PAIN.

  Patient problems: Pain

  MAUDE report 24167682 ↗
• InjuryJan 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE # 26 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN, EDEMA AND INFLAMMATION.

  Patient problems: Erosion; Pain; Unspecified Infection

  MAUDE report 24011924 ↗
• InjuryDec 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, PRIOR TO THE IMPLANT PLACEMENT, THE IMPLANT WAS NOT PLACED CORRECTLY ON THE DRILL CAUSING IT TO FALL OFF THE DRILL AND ONTO THE FLOOR WHERE IT LOST STERILITY. THE CUSTOMER INDICATED THAT THERE WAS NO ISSUE WITH THE DRILL. THE PROCEDURE WAS COMPLETED USING ANOTHER IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23855563 ↗
• MalfunctionNov 25, 2025Device Damaged Prior to Use; Device Damaged Prior to Use

  NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23648706 ↗
• InjuryNov 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT BECAME INFECTED, FAILING TO INTEGRATE. WILL ALLOW THE SITE TO HEAL TRADITIONALLY AND RE-ATTEMPT IN 2-3 MONTHS. UNKNOWN TOOTH LOCATION. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 23509048 ↗
• InjuryNov 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #12 WAS REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 23451354 ↗
• MalfunctionOct 31, 2025Mechanical Problem; Mechanical Problem

  NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23438591 ↗
• InjuryAug 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 22823809 ↗
• InjuryAug 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 22714407 ↗
• InjuryJun 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CALLED COMPLAINING OF PAIN. AFTER AN X-RAY AND EXAM, INFECTION WAS FOUND AROUND THE IMPLANT AT TOOTH SITE #25 (PALMER). THE IMPLANT WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

  Patient problems: Unspecified Infection

  MAUDE report 22307242 ↗
• InjuryJun 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANTS AT TOOTH SITES 42, 32 WERE REMOVED DUE TO BONE LOSS AND INFECTION.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 22121482 ↗
• InjuryMay 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS GIVEN ANTIBIOTICS DUE TO PERI-IMPLANTITIS BEFORE THE IMPLANT WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN, INFLAMMATION & EDEMA.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 22088031 ↗
• InjuryMay 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #10 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN, INFLAMMATION & EDEMA.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 22087974 ↗
• InjuryMay 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #23 WAS REMOVED DUE TO INFECTION & BONE LOSS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 22079286 ↗
• InjuryMay 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANTS WERE REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 21983222 ↗
• MalfunctionApr 17, 2025Fracture; Fracture

  IT WAS REPORTED CROWN CAME OFF IMPLANT. ATTEMPTED TO PLACE HEALING COLLAR ON IMPLANT UNTIL DENTIST COULD REPLACE CROWN, BUT THE HEX OF ABUTMENT WAS BROKEN. ATTEMPTED TO REMOVE BROKEN HEX BUT WAS UNABLE TO. THEREFORE IMPLANT WAS REMOVED AND REPLACED WITH 4.1X13 AND BONE GRAFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21855629 ↗
• InjuryApr 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO CBCT DETECTING IMPLANT WAS NOT IN THE BONE. UNDER STERILE PROTOCOL IMPLANT REMOVED. IMPLANT NOT IN SOCKET. TOOTH 26. SURGICAL REMOVAL OF IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21777747 ↗
• MalfunctionMar 24, 2025Component Missing; Component Missing

  IT WAS REPORTED IMPLANT WAS RECEIVED, HOWEVER WHEN CUSTOMER OPENED PLASTIC CONTAINER THERE WAS NO IMPLANT INSIDE. EVENT HAPPENED DURING A PROCEDURE BUT NO IMPACT TO THE PATIENT. USED NEW IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21676206 ↗
• InjuryMar 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED #7 EXTRACTED AND IMMEDIATE IMPLANT PLACEMENT WITH CERASORB GRAFT ON (B)(6) 2019. STAGE II (B)(6) 2019. PATIENT RETURNS (B)(6) 2023 WITH COMPLAINTS OF DRAINAGE THAT STARTED A YEAR AFTER CROWN WAS PLACED. ANTIBIOTICS WERE PRESCRIBED. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION, BONE LOSS, INFECTION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 21526311 ↗
• InjuryMar 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED #7 EXTRACTED AND IMMEDIATE IMPLANT PLACEMENT WITH CERASORB GRAFT ON (B)(6) 2019. STAGE II (B)(6) 2019. DRAINAGE REOCCURRED AND DECISION WAS MADE TO REMOVE THE IMPLANT DUE TO PERIIMPLANTITIS. ANTIBIOTIC PRESCRIBED. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION, BONE LOSS, INFECTION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 21525726 ↗
• InjuryMar 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED #7 EXTRACTED AND IMMEDIATE IMPLANT PLACEMENT WITH CERASORB GRAFT ON (B)(6) 2019. STAGE II (B)(6) 2019. PATIENT RETURNS WITH COMPLAINTS OF DRAINAGE THAT STARTED A YEAR AFTER CROWN WAS PLACED. SINCE THEN, UNDERWENT FLAP DEBRIDEMENT WITH TIME WITH PUROS AND BIOTIVITY MEMBRANE AND TREATMENT WITH ANTIBIOTICS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION, BONE LOSS, INFECTION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 21525599 ↗